Regulating Tobacco Standards: An Easy Fix in a Scientifically Uncertain Field

Last week, the New England Journal of Medicine published a study finding that smokers using reduced nicotine cigarettes smoked 30% fewer cigarettes and had reduced cravings at the end of the study compared to smokers using standard cigarettes. The lower-nicotine cigarettes had 0.4 mg of nicotine/gram compared to 15.8 mg of nicotine/gram for the standard cigarettes. Commentators were quick to point out that such studies could provide the evidence FDA needs to establish new nicotine standards for combustible cigarettes.

FDA has explicit authority from Congress to set low nicotine standards for cigarettes. The Family Smoking Prevent and Tobacco Control Act (FSPTCA) allows FDA to set “tobacco product standards,” including provisions for “nicotine yields of the product” where such standards are “appropriate for the protection of public health.” With a mountain of evidence showing that combustible cigarette addiction can lead to cancer, heart disease, and death, FDA should have no problem proving that nicotine standards for combustible cigarettes are appropriate.

FDA may have a harder task trying to show that nicotine reduction standards for other tobacco products are “appropriate for the protection of public health.” As one commentator noted, if the nicotine in combustible cigarettes declines, addicted smokers might switch to other nicotine-containing products, including smokeless-tobacco products, e-cigarettes, and e-pipes. Currently, no study has conclusively shown that smokeless tobacco products are safe or unsafe. Some studies suggest that smokeless tobacco products may lead to smoking later in life, while other studies show that smokeless tobacco may be helpful for smokers hoping to quit.

Even fewer studies show whether a tobacco product delivering nicotine, by itself, would be harmful. If industry produces a product that can deliver nicotine without cigarette’s accompanying chemicals, FDA may have an even harder time proving that nicotine standards for such products would be necessary to protect public health. Few studies have examined effects of nicotine addiction as separate from smoking. Indeed, some scientists believe that chronic nicotine use could potentially treat or prevent neurological disorders such as Parkinsons and ADHD.

This scientific uncertainty may be part of the reason why FDA has yet to establish nicotine standards for any tobacco product. Despite the contradictory studies on the safety of combustible cigarette substitutes, FDA should act quickly to introduce new nicotine standards for combustible cigarettes. New nicotine standards may mean that some smokers will switch to alternative tobacco products, where FDA’s justification for low nicotine standards is more likely to be challenged in court. But even if FDA only issues low nicotine standards for combustible cigarettes, any switch to other tobacco alternatives would likely still provide substantial public health benefits from reducing long-term combustible cigarette use.

cguo

cguo

2015-2016 Peter Barton Hutt Student Fellow During her fellowship year, Elizabeth Guo was a third year student in the JD/MPH Program at Harvard Law School and the Harvard School of Public Health. Her interests lie at the intersection of law, health care reimbursement, and biopharmaceutical regulation. Elizabeth graduated from Harvard University with a BA in social studies, focusing on the bioethics of assisted reproduction in China. Prior to law school, she was a senior associate at Avalere Health working with life science clients on a range of health policy topics, including Medicare coverage and reimbursement, biosimilar regulation, and healthcare quality programs. Elizabeth served as a student editor of the Journal of Law and Technology and a member of the Mississippi Delta Project’s Delta Project’s Food Policy Initiative. Elizabeth's fellowship paper was entitled: "Reputation and Judicial Deference: An Examination of FDA’s Reputation and Judicial Deference to Agency Action."

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